Cervical Interbody System Surgical Technique
Table of Contents Indications for Use................................1 Device Description............................... 1 Alamo C Instruments.............................. 1 Alamo C Implant Key Features..........................2 Surgical Technique............................... 3 Precautions, Contraindications, Potential Adverse Effects............. 6 Indications for Use: The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach. Device Description: The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with teeth to prevent back out and migration. Instruments Trial/Rasp Inserter Impactor 1
Key Features Aggressive teeth for secure fixation PEEK Version Tantalum markers for implant visualization Aggressive teeth for secure fixation Titanium Version Radiolucent windows for visibility Tecotex surface texture to facilitate bone fusion 7 Lordotic and 0 Parallel 7 Lordotic and 0 Parallel Large grafting area Large grafting area Implant Configurations 5mm-12mm (in 1mm increments) Tapered nose for ease of insertion 12mm 14mm 16mm Point of Attachment 14mm, 17mm, 20mm Secure point of attachment 2
Cervical Interbody System Surgical Technique Step 1: Preoperative Planning The appropriate Alamo C height should be estimated prior to surgery. In order to achieve maximal segment stability, it is essential to choose the largest possible implant that can be safely inserted without disturbing the surrounding neural elements. Step 2: Creating Disc Space Access Patient is placed in the supine position. The anterior cervical spine is exposed via the standard surgical approach. Step 3: Disc Space Preparation Perform a standard discectomy using instrumentation for an anterior cervical discectomy and fusion procedure. Using the Rasp end of the Double Ended Trial/Rasp for the estimated device height, scrape the cartilaginous layers from the surface of the adjacent vertebral end plates until bleeding bone is attained. Sufficient cleaning of the end plates is important for vascular supply to the bone graft. However, excessive cleaning may result in the removal of bone underlying the cartilaginous layers and weaken the end plates. 3
Step 4: Device Height Determination Select the trial that corresponds to the preoperative estimated height and best matches the prepared end plates. Each trial has a height and lordotic or parallel indicator. Insert the trial into the disc space. Apply gentle impaction and ensure that the trial fits tightly and accurately between the end plates. Using the largest possible device maximizes segment stability through the tension in the longitudinal ligament and annulous fibrosus. Step 5: Device Insertion Select the implant that corresponds to the trial. Attach the implant to the inserter by aligning the lateral pins with the flat surface of the implant and turning the handle to expose the internal threaded shaft. The threaded tip will engage with the central thread of the implant for secure attachment. Pack the grafting area of the implant with autologous bone graft. Insert the implant into the prepared intervertebral space. Gentle impaction on the inserter will assist in correct positioning. Release the inserter by turning the handle counter-clockwise to disengage from the implant. If additional positioning is required, the Impactor may be used with a mallet to move the implant to the desired location. 4
Step 6: Verifying Implant Placement Remove all instruments and verify the optimal position using fluoroscopy. The diagrams below illustrate the superior/inferior, anterior, and sagittal views showing the location of the X-ray markers for the PEEK implant and the Titanium implant respectively. PEEK Version Titanium Version AXIAL VIEW AXIAL VIEW STRAIGHT AP VIEW LATERAL VIEW STRAIGHT AP VIEW LATERAL VIEW 1.5mm (for 14 x 12mm) 1.7mm (for 17 x 14mm) 2.0mm (for 20 x 16mm) 0.9mm Step 7: Supplemental Fixation Use of a FDA cleared anterior cervical plate is required for supplemental fixation with this device. Step 8: Removal or Revision The device can be removed by breaking the fused bone/device interface with a cutting tool such as an Osteotome or Chisel. Once the device is loose, attach the inserter and pull the device from the disc space. If additional force is required, a strong forceps instrument such as Kocher forceps or a hemostat can be used to retrieve the device. 5
Precautions: Only patients that meet the criteria described in the indications should be selected and the implantation of the interbody fusion device should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant size. Based on the fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level and other patient conditions which may impact the performance of the system. Care should be taken in the handling and storage of the implant. The implants should not be scratched, notched or damaged during surgery. Alterations will produce defects in surface finish and internal stresses, which may become the focal point for eventual breakage of the implant. The Alamo C has not been evaluated for safety and compatibility in the MR environment. The Alamo C has not been tested for heating or migration in the MR environment. The use of dissimilar metals is prohibited as rapid corrosion can occur. Components of this system should not be used with components of any other system or manufacturer. Contraindications: Contraindications include, but are not limited to: 1. Any case where there is active systemic infection, infection localized to the site of the proposed implantation 2. A patient with rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication because it may limit the amount of fixation and thus preclude the use of this or any other spinal instrumentation system 3. A patient that does not meet the criteria described in the indications 4. Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count 5. An overweight or obese patient as these patients can produce additional loads on the device that can cause failure of the device or subsidence 6. Any patient that is non-compliant with post-operative instructions 7. Patients who smoke have been observed to experience higher rates of pseudoarthrosis following surgical procedures where bone graft is used 8. Pregnancy 9. Signs of local inflammation 10. Fever or leukocytosis 11. Any case where the patient s occupation, activity level, or lifestyle can place undue stress on the implant that leads to failure. Specifically patients with mental illness, alcoholism, or drug abuse Potential Adverse Effects: Possible adverse events or complications include, but are not limited to: 1. Bone loss or decrease in bone density due to stress shielding 2. Non-union (pseudoarthrosis), delayed union 3. Bending and/or breakage of the implant 4. Posterior or anterior implant migration and/or subsidence 5. Allergy or foreign body sensitivity to any of the implant material 6. Tissue or nerve damage, irrigation, and/or pain caused by improper positioning and placement of the implant 7. Infection 8. Pain, discomfort, or abnormal sensations due to the presence of the device 9. Post-operative change in spinal curvature, loss of correction, height and/or reduction 10. Loss of neurological function including complete or incomplete paralysis, dysesthesia, hyperesthesia, paraesthesia, appearance or radiculopathy 11. Death 12. Erosion of blood vessels due to the proximity of the device leading to hemorrhage and/or death CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSCIAN. Please refer to the Instructions For Use included with the product for complete instructions, indications, contraindications, and warnings. 6
1412I-005 0100-1405 14mm x 12mm x 5mm x 0 1412I-006 0100-1406 14mm x 12mm x 6mm x 0 1412I-007 0100-1407 14mm x 12mm x 7mm x 0 1412I-008 0100-1408 14mm x 12mm x 8mm x 0 1412I-009 0100-1409 14mm x 12mm x 9mm x 0 1412I-010 0100-1410 14mm x 12mm x 10mm x 0 1412I-011 0100-1411 14mm x 12mm x 11mm x 0 1412I-012 0100-1412 14mm x 12mm x 12mm x 0 1412I-705 0107-1405 14mm x 12mm x 5mm x 7 1412I-706 0107-1406 14mm x 12mm x 6mm x 7 1412I-707 0107-1407 14mm x 12mm x 7mm x 7 1412I-708 0107-1408 14mm x 12mm x 8mm x 7 1412I-709 0107-1409 14mm x 12mm x 9mm x 7 1412I-710 0107-1410 14mm x 12mm x 10mm x 7 1412I-711 0107-1411 14mm x 12mm x 11mm x 7 1412I-712 0107-1412 14mm x 12mm x 12mm x 7 1714I-005 0100-1705 17mm x 14mm x 5mm x 0 1714I-006 0100-1706 17mm x 14mm x 6mm x 0 1714I-007 0100-1707 17mm x 14mm x 7mm x 0 1714I-008 0100-1708 17mm x 14mm x 8mm x 0 1714I-009 0100-1709 17mm x 14mm x 9mm x 0 1714I-010 0100-1710 17mm x 14mm x 10mm x 0 1714I-011 0100-1711 17mm x 14mm x 11mm x 0 1714I-012 0100-1712 17mm x 14mm x 12mm x 0 1714I-705 0107-1705 17mm x 14mm x 5mm x 7 1714I-706 0107-1706 17mm x 14mm x 6mm x 7 1714I-707 0107-1707 17mm x 14mm x 7mm x 7 1714I-708 0107-1708 17mm x 14mm x 8mm x 7 1714I-709 0107-1709 17mm x 14mm x 9mm x 7 1714I-710 0107-1710 17mm x 14mm x 10mm x 7 1714I-711 0107-1711 17mm x 14mm x 11mm x 7 1714I-712 0107-1712 17mm x 14mm x 12mm x 7 2016I-005-20mm x 16mm x 5mm x 0 2016I-006-20mm x 16mm x 6mm x 0 2016I-007-20mm x 16mm x 7mm x 0 2016I-008-20mm x 16mm x 8mm x 0 2016I-009-20mm x 16mm x 9mm x 0 2016I-010-20mm x 16mm x 10mm x 0 2016I-011-20mm x 16mm x 11mm x 0 2016I-012-20mm x 16mm x 12mm x 0 2016I-705-20mm x 16mm x 5mm x 7 2016I-706-20mm x 16mm x 6mm x 7 2016I-707-20mm x 16mm x 7mm x 7 2016I-708-20mm x 16mm x 8mm x 7 2016I-709-20mm x 16mm x 9mm x 7 2016I-710-20mm x 16mm x 10mm x 7 2016I-711-20mm x 16mm x 11mm x 7 2016I-712-20mm x 16mm x 12mm x 7 14206 Northbrook Dr San Antonio, TX 78232 P:(210) 314-2525 F:(210) 314-2524 E: info@alliance-spine.com www.alliance-spine.com MKT-100 Rev. H